Approach G50792Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002507920), received between Jul 25, 2016 and Nov 1, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 5, 2026Open, Classified

   Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

   Z-1777-2026 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

2. Oct 8, 2024Open, Classified

   Affected device lots have labels that state the incorrect expiration dates.

   Z-0346-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Break; Unraveled Material; Break; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049861 ↗
• InjuryOct 4, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9155779 ↗
• MalfunctionSep 20, 2018Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDE WIRE WAS EXHIBITING RESISTANCE WHILE MOVING THROUGH THE CATHETER. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THAT THE TIP HAD BEGUN TO UNRAVEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7895172 ↗
• MalfunctionAug 11, 2017Sticking; Sticking

  IT WAS REPORTED THAT DURING A LOWER LEG ANGIOGRAM, AN APPROACH CTO MICROWIRE WIRE GUIDE BECAME STUCK IN THE CATHETER WHEN REMOVING. THE SAME PROBLEM WAS REPORTED WITH TWO OTHER WIRE GUIDES. EACH DEVICE IS BEING REPORTED AND DOCUMENTED IN THE FOLLOWING REPORT NUMBERS: 1820334-2017-02072, 1820334-2017-02073, 1820334-2017-02114, AND 1820334-2017-02115. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6788791 ↗
• MalfunctionJun 2, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANTEGRADE APPROACH TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) /POPLITEAL CHRONIC TOTAL OCCLUSION (CTO) FOR REVASCULARIZATION WHILE USING A CTO MICROWIRE 25G WIRE GUIDE TO PUSH THROUGH THE CHRONIC TOTAL OCCLUSION, THAT WAS OBVIOUSLY SUBINTIMAL, THE PHYSICIAN COULD FEEL THE WIRE DRAGGING AND COULD SEE A DEFECT AT THE TIP OF THE WIRE WHEN IT WAS REMOVED. THE PHYSICIAN THEN MOVED TO 18G CTO WIRE AND NOTICED THE SAME FEELING. THE WIRE TIP DIDN'T APPEAR TO HAVE A DEFECT, BUT TISSUE/BLOOD WAS ON THE TIP. THERE WAS NO DAMAGE TO THE VESSEL REPORTED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6608314 ↗
• MalfunctionJul 26, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A REVASCULARIZATION OF A LOWER LEG PROCEDURE A SPINNER STRIPPED THE COATING FROM A WIRE. THE PHYSICIAN HAD ANTERIOR TIBIAL ARTERY ACCESS AS WELL AS COMMON FEMORAL ACCESS CONTRALATERAL. THE PHYSICIAN ATTEMPTED TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) AT THE AREA OF THE DISTAL POPLITEAL ANTERIOR TIBIAL VESSEL. THE PHYSICIAN WAS USING THE WIRE THROUGH A CATHETER AND WAS USING A SPINNER TORQUE DEVICE. THE SPINNER WAS BEING USED TO SPIN THE WIRE IN ORDER TO CROSS THE CTO. THIS WAS NOT SUCCESSFUL. WHEN THE WIRE WAS REMOVED IT WAS NOTICED THAT THERE WAS SOMETHING ON THE TIP OF THE WIRE. THE MATTER ON THE TIP OF THE WIRE WAS THE COATING OF THE WIRE THAT THE SPINNER HAD STRIPPED OFF. IT DID NOT APPEAR THAT ANY WIRE COATING BECAME FREE INSIDE OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5822683 ↗
• MalfunctionJul 25, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A REVASCULARIZATION OF A LOWER LEG PROCEDURE A SPINNER STRIPPED THE COATING FROM A WIRE. THE PHYSICIAN HAD ANTERIOR TIBIAL ARTERY ACCESS AS WELL AS COMMON FEMORAL ACCESS CONTRALATERAL. THE PHYSICIAN ATTEMPTED TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) AT THE AREA OF THE DISTAL POPLITEAL ANTERIOR TIBIAL VESSEL. THE PHYSICIAN WAS USING THE WIRE THROUGH A CATHETER AND WAS USING A SPINNER TORQUE DEVICE. THE SPINNER WAS BEING USED TO SPIN THE WIRE IN ORDER TO CROSS THE CTO. THIS WAS NOT SUCCESSFUL. WHEN THE WIRE WAS REMOVED IT WAS NOTICED THAT THERE WAS SOMETHING ON THE TIP OF THE WIRE. THE MATTER ON THE TIP OF THE WIRE WAS THE COATING OF THE WIRE THAT THE SPINNER HAD STRIPPED OFF. IT DID NOT APPEAR THAT ANY WIRE COATING BECAME FREE INSIDE OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5818730 ↗